Shanghai Pharmaceuticals industry park design (Shanghai Pharma)

Fast-ex­pand­ing Shang­hai Phar­ma breaks ground on $1.8B biotech park fo­cused on next-gen R&D, an­ti­body pro­duc­tion

One of Chi­na’s biggest bio­phar­ma com­pa­nies is hit­ting the ground run­ning in 2021.

Shang­hai Phar­ma­ceu­ti­cals broke ground Mon­day on a $1.8 bil­lion, 3.2 mil­lion-square-foot in­dus­tri­al park ded­i­cat­ed to R&D work in the bustling field of cell and gene ther­a­pies as well as man­u­fac­tur­ing ther­a­peu­tic an­ti­bod­ies, the firm said.

The mas­sive site is lo­cat­ed in Pudong New Area’s Zhangjiang area and will see con­struc­tion take place in two phas­es — 1.08 mil­lion square feet for the first, and 2.15 mil­lion square feet for the sec­ond. News of the ground­break­ing and ex­pan­sion project was first re­port­ed by SHINE, a dig­i­tal news out­let of the Shang­hai Dai­ly.

Zuo Min, Shang­hai Phar­ma’s ex­ec­u­tive di­rec­tor and pres­i­dent, said the bio­phar­ma in­dus­try park will fea­ture both in­no­va­tion-in­cu­ba­tion-ser­vice and in­dus­tri­al­iza­tion plat­forms to help star­tups com­mer­cial­ize lab re­search projects, SHINE re­port­ed.

“The new site could great­ly ex­pe­dite new drug re­search and the com­mer­cial­iza­tion process in Shang­hai, mak­ing the city more at­trac­tive for new re­search projects from home and abroad,” Zuo said.

The in­cu­ba­tion plat­form will cov­er rough­ly 538,000 square feet while an­oth­er 861,000 square feet will be al­lo­cat­ed for an­ti­body man­u­fac­tur­ing fa­cil­i­ties, the com­pa­ny said. The to­tal vol­ume of an­ti­body re­ac­tors is ex­pect­ed to reach 120,000 liters.

Shang­hai Phar­ma’s man­u­fac­tur­ing ca­pac­i­ties cur­rent­ly fo­cus on ther­a­peu­tics in on­col­o­gy, cere­bro­car­dio­vas­cu­lar dis­eases, CNS drugs, and im­munol­o­gy, among oth­er ar­eas.

Over the past three years, the com­pa­ny has worked to ex­pand not on­ly in Chi­na, but in the US and Eu­rope as well. In 2018, the com­pa­ny pub­li­cized its in­tent to hunt for Amer­i­can man­u­fac­tur­ing and R&D cor­po­ra­tions that it could part­ner with and ac­quire Chi­na rights from to bol­ster its dis­tri­b­u­tion busi­ness.

As part of those ef­forts, the com­pa­ny opened a fa­cil­i­ty in San Diego in 2018, which has quick­ly launched ef­forts in myr­i­ad on­col­o­gy drug and an­ti­body pro­grams.

Shang­hai’s pipeline in­cludes cirm­tuzum­ab, a mon­o­clon­al an­ti­body drug that tar­gets man­tle cell lym­phoma and chron­ic lym­pho­cyt­ic leukemia, in Phase I/II clin­i­cal tri­als, ac­cord­ing to the con­glom­er­ate’s web­site. It al­so has TK216, a small mol­e­cule seek­ing to tar­get Ew­ing sar­co­mas—which present as pe­di­atric bone and soft tis­sue can­cer— in a Phase I study in pa­tients with re­lapsed or re­frac­to­ry Ew­ing sar­co­mas.

The drug­mak­er is al­so in pre­clin­i­cal de­vel­op­ment of ROR1 CAR-T, a cell ther­a­py which doesn’t at­tack healthy cell tis­sue but may pro­vide im­mune re­spons­es to can­cer­ous cells in hema­to­log­ic and sol­id tu­mors. The San Diego site is aid­ing its Shang­hai home base with test­ing and de­vel­op­ment of On­corine, or on­colyt­ic virus­es, which pref­er­en­tial­ly in­fect and kill can­cer cells.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.